510(k) K032396 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 21, 2003 |
| Received | Aug 4, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2018 | Zimmer Biomet, Inc. Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis
The device is used in treatment of patients who Terminated |
LPH | None listed |
| Sep 15, 2017 | Zimmer Biomet, Inc. 36MM COCR MODULAR HD -6MM Terminated |
JDI | None listed |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Hips
Active Articulation ArComXL Bearings
Active Articulation E1 Bearings
Arcos Taper Cap
BIOLOX delta Option Head
E1 RingLoc Bi-Polar
Freedom Constrained Liner +5mm
Hi Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.